Trial Outcomes & Findings for Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF) (NCT NCT01366209)
NCT ID: NCT01366209
Last Updated: 2017-04-05
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
555 participants
Primary outcome timeframe
52 weeks
Results posted on
2017-04-05
Participant Flow
Participant milestones
| Measure |
Active Arm
Pirfenidone: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
|
Placebo Arm
Placebo: Placebo equivalent given as 3 divided doses 3 times per day.
|
|---|---|---|
|
Overall Study
STARTED
|
278
|
277
|
|
Overall Study
COMPLETED
|
243
|
241
|
|
Overall Study
NOT COMPLETED
|
35
|
36
|
Reasons for withdrawal
| Measure |
Active Arm
Pirfenidone: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
|
Placebo Arm
Placebo: Placebo equivalent given as 3 divided doses 3 times per day.
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
7
|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
|
Overall Study
Death
|
12
|
19
|
|
Overall Study
Lung transplantation
|
6
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Sponsors decision
|
0
|
1
|
|
Overall Study
Withdrew consent
|
4
|
3
|
Baseline Characteristics
Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Baseline characteristics by cohort
| Measure |
Active Arm
n=278 Participants
Pirfenidone: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
|
Placebo Arm
n=277 Participants
Placebo: Placebo equivalent given as 3 divided doses 3 times per day.
|
Total
n=555 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
73 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
161 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
205 Participants
n=5 Participants
|
189 Participants
n=7 Participants
|
394 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
222 Participants
n=5 Participants
|
213 Participants
n=7 Participants
|
435 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
187 participants
n=5 Participants
|
184 participants
n=7 Participants
|
371 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
33 participants
n=5 Participants
|
31 participants
n=7 Participants
|
64 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
15 participants
n=5 Participants
|
16 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Region of Enrollment
Croatia
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
12 participants
n=5 Participants
|
5 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Peru
|
18 participants
n=5 Participants
|
26 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: Intent to Treat all randomized Patient
Outcome measures
| Measure |
Active Arm
n=278 Participants
Pirfenidone: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
|
Placebo Arm
n=277 Participants
Placebo: Placebo equivalent given as 3 divided doses 3 times per day.
|
|---|---|---|
|
Change in Percent Predicted Forced Vital Capacity (%FVC) From Baseline to Week 52
Decline or >=10% or Death
|
16.5 percentage of patients
|
31.8 percentage of patients
|
|
Change in Percent Predicted Forced Vital Capacity (%FVC) From Baseline to Week 52
No Decline (Change >0%)
|
22.7 percentage of patients
|
9.7 percentage of patients
|
Adverse Events
Active Arm
Serious events: 55 serious events
Other events: 271 other events
Deaths: 0 deaths
Placebo Arm
Serious events: 69 serious events
Other events: 253 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active Arm
n=278 participants at risk
Pirfenidone: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
|
Placebo Arm
n=277 participants at risk
Placebo: Placebo equivalent given as 3 divided doses 3 times per day.
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.36%
1/278 • Number of events 2 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Cardiac disorders
Angina Pectoris
|
1.1%
3/278 • Number of events 4 • 1 year
|
0.00%
0/277 • 1 year
|
|
Cardiac disorders
Arrhythmia
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Cardiac disorders
Atrial Fibrillation
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.72%
2/277 • Number of events 2 • 1 year
|
|
Cardiac disorders
Atrial Flutter
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Cardiac disorders
Atrioventricular Block
|
0.00%
0/278 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiac Arrest
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.72%
2/278 • Number of events 2 • 1 year
|
0.00%
0/277 • 1 year
|
|
Cardiac disorders
Cor Pulmonale
|
0.00%
0/278 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Cardiac disorders
Coronary Artery Occlusion
|
0.00%
0/278 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Cardiac disorders
Coronary Artery Disease
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Cardiac disorders
Mitral Valve Incompetence
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Cardiac disorders
Myocardial Infarction
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Cardiac disorders
Palpitations
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Cardiac disorders
Sick Sinus Syndrome
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/278 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Gastrointestinal disorders
Colitis Ulcerative
|
0.00%
0/278 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Duodenal Ulcer Haemorrhage
|
0.00%
0/278 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Gastrointestinal disorders
Ileus
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Gastrointestinal disorders
Melaena
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
1.1%
3/278 • Number of events 3 • 1 year
|
0.00%
0/277 • 1 year
|
|
Gastrointestinal disorders
Peptic Ulcer Haemorrhage
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Gastrointestinal disorders
Umbilical Hernia Obstructive
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Gastrointestinal disorders
Volvulus
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
General disorders
Non-cardiac chest pain
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Hepatitis
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Infections and infestations
Bronchitis
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.72%
2/277 • Number of events 2 • 1 year
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/278 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/278 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/278 • 1 year
|
0.72%
2/277 • Number of events 2 • 1 year
|
|
Infections and infestations
Influenza
|
0.00%
0/278 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Infections and infestations
Lower respiratiory tract infection
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.00%
0/278 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/278 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Infections and infestations
pneumonia
|
4.0%
11/278 • Number of events 11 • 1 year
|
5.1%
14/277 • Number of events 16 • 1 year
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/278 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/278 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Infections and infestations
Septic shock
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.72%
2/277 • Number of events 2 • 1 year
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/278 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/278 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.72%
2/278 • Number of events 2 • 1 year
|
0.00%
0/277 • 1 year
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Investigations
Weight decreased
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/278 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/278 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/278 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/278 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/278 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.00%
0/278 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/278 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypopharyngeal cancer
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.72%
2/278 • Number of events 2 • 1 year
|
1.4%
4/277 • Number of events 4 • 1 year
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/278 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Nervous system disorders
Haemorrhage intercranial
|
0.00%
0/278 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/278 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Nervous system disorders
Ischaemic stroke
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Nervous system disorders
IVth nerve paralysis
|
0.00%
0/278 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/278 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Nervous system disorders
Spinal cord compression
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Nervous system disorders
Syncope
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/278 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Psychotic disorder
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/278 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Renal failure
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Urethral pain
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Renal and urinary disorders
Urinary retention
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.72%
2/277 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
2.5%
7/278 • Number of events 11 • 1 year
|
9.7%
27/277 • Number of events 32 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.00%
0/277 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous tension
|
0.00%
0/278 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.00%
0/278 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.72%
2/277 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.36%
1/278 • Number of events 1 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/278 • 1 year
|
0.72%
2/277 • Number of events 2 • 1 year
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/278 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Vascular disorders
Hypotension
|
0.00%
0/278 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
0.36%
1/278 • 1 year
|
0.36%
1/277 • 1 year
|
Other adverse events
| Measure |
Active Arm
n=278 participants at risk
Pirfenidone: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
|
Placebo Arm
n=277 participants at risk
Placebo: Placebo equivalent given as 3 divided doses 3 times per day.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.2%
20/278 • Number of events 33 • 1 year
|
4.3%
12/277 • Number of events 14 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
11.5%
32/278 • Number of events 38 • 1 year
|
13.7%
38/277 • Number of events 39 • 1 year
|
|
Gastrointestinal disorders
Diarrhoea
|
22.3%
62/278 • Number of events 112 • 1 year
|
21.7%
60/277 • Number of events 101 • 1 year
|
|
Gastrointestinal disorders
Dyspepsia
|
17.6%
49/278 • Number of events 61 • 1 year
|
6.1%
17/277 • Number of events 22 • 1 year
|
|
Gastrointestinal disorders
Flatulence
|
4.3%
12/278 • Number of events 13 • 1 year
|
6.1%
17/277 • Number of events 18 • 1 year
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux
|
11.9%
33/278 • Number of events 36 • 1 year
|
6.5%
18/277 • Number of events 21 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
36.0%
100/278 • Number of events 138 • 1 year
|
13.4%
37/277 • Number of events 46 • 1 year
|
|
Gastrointestinal disorders
Stomach Discomfort
|
8.6%
24/278 • Number of events 38 • 1 year
|
4.3%
12/277 • Number of events 15 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
12.9%
36/278 • Number of events 74 • 1 year
|
8.7%
24/277 • Number of events 28 • 1 year
|
|
General disorders
Asthenia
|
5.8%
16/278 • Number of events 17 • 1 year
|
4.0%
11/277 • Number of events 12 • 1 year
|
|
General disorders
Oedema peripheral
|
3.2%
9/278 • Number of events 9 • 1 year
|
8.3%
23/277 • Number of events 24 • 1 year
|
|
General disorders
Pyrexia
|
2.2%
6/278 • Number of events 7 • 1 year
|
6.1%
17/277 • Number of events 20 • 1 year
|
|
Infections and infestations
Bronchitis
|
13.7%
38/278 • Number of events 50 • 1 year
|
12.3%
34/277 • Number of events 49 • 1 year
|
|
Infections and infestations
Influenza
|
5.0%
14/278 • Number of events 16 • 1 year
|
4.3%
12/277 • Number of events 12 • 1 year
|
|
Infections and infestations
Lower respiratory tract infection
|
4.0%
11/278 • Number of events 13 • 1 year
|
6.9%
19/277 • Number of events 23 • 1 year
|
|
Infections and infestations
Nasopharyngitis
|
11.9%
33/278 • Number of events 45 • 1 year
|
10.8%
30/277 • Number of events 40 • 1 year
|
|
Infections and infestations
Sinusitis
|
7.2%
20/278 • Number of events 25 • 1 year
|
8.7%
24/277 • Number of events 32 • 1 year
|
|
Infections and infestations
Upper respiratory tract infection
|
21.9%
61/278 • Number of events 78 • 1 year
|
20.2%
56/277 • Number of events 79 • 1 year
|
|
Investigations
Weight decreased
|
12.6%
35/278 • Number of events 35 • 1 year
|
7.9%
22/277 • Number of events 23 • 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
15.8%
44/278 • Number of events 47 • 1 year
|
6.5%
18/277 • Number of events 19 • 1 year
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.2%
20/278 • Number of events 23 • 1 year
|
3.6%
10/277 • Number of events 10 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.4%
26/278 • Number of events 36 • 1 year
|
7.2%
20/277 • Number of events 33 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.8%
30/278 • Number of events 35 • 1 year
|
13.4%
37/277 • Number of events 42 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.0%
14/278 • Number of events 14 • 1 year
|
3.2%
9/277 • Number of events 11 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
14/278 • Number of events 18 • 1 year
|
5.8%
16/277 • Number of events 18 • 1 year
|
|
Nervous system disorders
Dizziness
|
17.6%
49/278 • Number of events 88 • 1 year
|
13.0%
36/277 • Number of events 43 • 1 year
|
|
Nervous system disorders
Dysgeusia
|
9.0%
25/278 • Number of events 26 • 1 year
|
4.0%
11/277 • Number of events 12 • 1 year
|
|
Nervous system disorders
Headache
|
25.9%
72/278 • Number of events 117 • 1 year
|
23.1%
64/277 • Number of events 96 • 1 year
|
|
Psychiatric disorders
Anxiety
|
2.9%
8/278 • Number of events 8 • 1 year
|
5.1%
14/277 • Number of events 14 • 1 year
|
|
Psychiatric disorders
Depression
|
3.2%
9/278 • Number of events 9 • 1 year
|
5.1%
14/277 • Number of events 14 • 1 year
|
|
Psychiatric disorders
Insomnia
|
11.2%
31/278 • Number of events 33 • 1 year
|
6.5%
18/277 • Number of events 21 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.2%
70/278 • Number of events 104 • 1 year
|
29.6%
82/277 • Number of events 97 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
14.7%
41/278 • Number of events 49 • 1 year
|
17.7%
49/277 • Number of events 66 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
6.8%
19/278 • Number of events 21 • 1 year
|
11.6%
32/277 • Number of events 43 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
5.0%
14/278 • Number of events 14 • 1 year
|
7.2%
20/277 • Number of events 21 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.2%
9/278 • Number of events 11 • 1 year
|
5.1%
14/277 • Number of events 14 • 1 year
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
5.8%
16/278 • Number of events 25 • 1 year
|
0.36%
1/277 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
9.7%
27/278 • Number of events 35 • 1 year
|
6.9%
19/277 • Number of events 20 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
28.1%
78/278 • Number of events 123 • 1 year
|
8.7%
24/277 • Number of events 27 • 1 year
|
|
General disorders
Fatigue
|
20.9%
58/278 • Number of events 93 • 1 year
|
17.3%
48/277 • Number of events 55 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
2.9%
8/278 • Number of events 12 • 1 year
|
6.1%
17/277 • Number of events 28 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place